Maxicamera 400T W/Body Contour Tomogra

FDA 510(k) K841996 · General Electric Co.

Substantially Equivalent

510(k) numberK841996

Submission

Device name
Maxicamera 400T W/Body Contour Tomogra
Applicant
General Electric Co.
Walker, MI, US
Received
May 16, 1984
Decision date
July 16, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAM – Scanner, Whole Body, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1330
Specialty
Radiology

Other 510(k)s with product code JAM

510(k)DeviceApplicantDecision
K842895Wba - I.R.I.S.JAM · Traditional Siemens Gammasonics, Inc.08/27/1984SE
K770530Cleon ImagerJAM · Traditional Union Carbide Corp.04/05/1977SE

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Questions and answers

When was Maxicamera 400T W/Body Contour Tomogra cleared by the FDA?

Maxicamera 400T W/Body Contour Tomogra (K841996) received a 510(k) decision of Substantially Equivalent on July 16, 1984, 61 days after the submission was received.

What is the product code of K841996?

The FDA product code is JAM – Scanner, Whole Body, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1330.